Deep Brain Stimulation (DBS) for Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00658125
Recruitment Status : Unknown
Verified January 2010 by University Health Network, Toronto.
Recruitment status was:  Active, not recruiting
First Posted : April 14, 2008
Last Update Posted : April 8, 2010
Information provided by:
University Health Network, Toronto

April 9, 2008
April 14, 2008
April 8, 2010
March 2007
June 2010   (Final data collection date for primary outcome measure)
memory performance on neuropsychological tests [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT00658125 on Archive Site
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Deep Brain Stimulation (DBS) for Alzheimer's Disease
Modulation of Cognitive Function Using Electrical Brain Stimulation in Patients With Early Alzheimer Disease

Background: Alzheimer disease (AD) is a debilitating brain disorder that affects over 4.75 million people in the US and Canada. People with AD have difficulty remembering general facts and previously experienced autobiographical events. Animal and human research demonstrates that this type of memory depends on neural function within specific brain areas, and that it may be possible to enhance memory with electrical stimulation of these brain areas. We have recently shown that deep brain stimulation (DBS) of a brain area called the fornix enhances memory in a human.

Hypotheses: We hypothesize that fornix DBS will safely enhance memory in early AD patients by activating memory circuits in the brain.

Methods: Six early AD patients will take part in a phase I clinical study over a 1-year period. The study involves bilateral fornix DBS implantation, detailed neuropsychological and neurological testing, and brain imaging to detect alterations in brain activity induced by stimulation. These assessments will occur one month before surgery, then again at one month, 6 months, and 12 months after surgery.

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Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Alzheimer Disease
Procedure: Deep Brain Stimulation (Fornix DBS)
Fornix DBS for Alzheimer Disease
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Hamani C, McAndrews MP, Cohn M, Oh M, Zumsteg D, Shapiro CM, Wennberg RA, Lozano AM. Memory enhancement induced by hypothalamic/fornix deep brain stimulation. Ann Neurol. 2008 Jan;63(1):119-23. doi: 10.1002/ana.21295.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women aged 40 to 80 years old, who
  • Satisfy the diagnostic criteria for probable AD,
  • Have received the diagnosis of AD within the past 2 years,
  • Have a CDR of 0.5 or 1.0, and
  • Score between 20 and 28 on the Mini Mental State Examination

Exclusion Criteria:

  • Pre-existing structural brain abnormalities,
  • Other neurologic or psychiatric diagnoses, or
  • Medical comorbidities that would preclude them from undergoing surgery
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Andres Lozano, Professor, University of Toronto
University Health Network, Toronto
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Study Director: Adrian W Laxton, MD Toronto Western Research Institute
Principal Investigator: Andres M Lozano, MD, PhD Toronto Western Research Institute
Principal Investigator: David Tang-Wai, MD Toronto Western Research Institute
University Health Network, Toronto
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP